U.S. Patent No. 10,238,760
TEEClean Automated TEE Probe Cleaner Disinfector is the first product of its kind to be cleared by the US FDA. Designed exclusively for transesophageal echocardiogram ultrasound probes (TEE), TEEClean provides both manufacturers recommended cleaning and high-level disinfection of soiled TEE probes in the same device.
Current methods require manual cleaning to be completed so as to achieve proper high-level disinfection. TEEClean allows the healthcare professional to simply place a bedside cleaned TEE probe into the device, removing the potential of an ineffectively cleaned TEE probe being high-level disinfected.
CS Medical has been our vendor for our TEE reprocessing for our TEE probes for greater than 5 years. They have consistently provided quality products that have ensured our compliance with HLD for this reusable medical devices. They have shown innovation in products that meet and exceed regulatory and best practice standards.
TEEClean is the first
Automated Ultrasound Reprocessor
cleared by the US FDA
TEEClean provides both a scientifically verified and repeatable method for cleaning of soiled TEE probe. Incorporated in TEEClean is TEEZyme®, an enzymatic solution that is injected into the cleaning and disinfection reservoir once a soiled TEE probe has been properly inserted. The TEEClean microprocessor controller then monitors all parameters of the cleaning step to ensure completion prior to high-level disinfection. After cleaning, TEEClean begins the validated and repeatable high-level disinfection process.
Using TEEClean is simple
One minute of the technician's time to interact with TEEClean will begin the process of cleaning and high-level disinfecting a soiled TEE ultrasound probe.
TEEClean stores up to 99 unique user names and assigns user numbers to all trained technicians that use the device with scanning of a barcode associated with the user number or through a manual lookup on the LCD touchscreen.
TEEClean stores a list of all TEE probes that could be cleaned and disinfected with the device. TEEClean will manage up to 99 individual TEE probes.
Perform Electrical Leakage Test
TEEClean provides prompts for completion of electrical leakage testing. Electrical leakage testing results are then recorded in TEEClean by the technician and then printed on the verification record as well as stored in system memory.
TEEClean incorporates an FDA validated cleaning method and removes the labor and time intensive manual portion of this process. TEEClean automates the enzymatic soak that has traditionally occurred in a sink or basin. By removing the manual process, TEEClean significantly reduces the handling of the delicate transducer of the TEE probe thus further reducing the chance for damage. Cleaning is the most important element to the proper reprocessing of any reusable medical device. Without effective cleaning of the reusable medical device any disinfectant or sterilant cannot properly work.
TEEClean provides electronic records retention of the clean and disinfection cycle and records device maintenance events. A printed record is provided with the built-in thermal printer
To use TEEClean simply place the bedside enzymatically treated, soiled TEE Probe directly into TEEClean, no additional steps required. Then, by following simple prompts on the color LCD display, the healthcare professional will enter information about the probe, disinfectant chemistry used for high-level disinfection and if the probe passed electrical leakage testing.
TEEClean is designed to provide cleaning and high-level disinfection of transesophageal ultrasound probes. The system has been cleared for use with TD-5 and TD-8 high-level disinfectants. These products have been cleared under 510(k) number K182891.
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